StrokeHST2NCT06268041
HIT-Stroke Trial 2
A study testing Moderate-Intensity Aerobic Training and High-Intensity Interval Training in people with Stroke, run by University of Cincinnati at 3 sites in United States.
Trial summary
People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Moderate-Intensity Aerobic Training and High-Intensity Interval Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Feb 2024to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-85 years at time of consenting
- Hemiparesis from ischemic and/or hemorrhagic strokes
- Most recent stroke for which participant sought treatment, at least 6 months prior to study consent
- Walking speed <1.0 m/s on the 10-meter walk test
- Able to walk 10m over ground with assistive devices as needed and no continuous physical assistance from another person (guarding and intermittent assistance for loss of balance allowed)
- Able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph)
- Stable cardiovascular condition (AHA class B, allowing for aerobic capacity <6 metabolic equivalents)
- Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions
Who cannot join
- Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG abnormality that makes exercise ECG uninterpretable for ischemia and no other clinical testing from the past year available to rule out these conditions)
- Evidence of significant arrhythmia or myocardial ischemia on treadmill ECG graded exercise test in the absence of recent (past year) more definitive clinical testing (e.g. stress nuclear imaging) with negative result
- Hospitalization for cardiac or pulmonary disease within past 3 months
- Implanted pacemaker or defibrillator with an upper heart rate limit that would interfere with exercise testing or prescription, or with unknown limit
- Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
- Severe lower limb spasticity (Ashworth >2)
Show all 16Show fewer
- Known recent history (<3 months) of unstable substance abuse or unstable mental illness
- Major post-stroke depression (Patient Health Questionnaire [PHQ-9] ≥ 10) in the absence of depression management by a health care provider
- Currently participating in physical therapy or another interventional study targeting walking function
- Recent (<2 weeks) or planned changes in lower limb orthotic or spasticity management
- Foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist
- Clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke
- Unable to walk outside the home prior to stroke
- Other significant medical condition likely to limit improvement or jeopardize safety as assessed by a physical therapist (e.g. joint contracture, gait limited by pain)
- Pregnancy
- Previous exposure to fast treadmill walking (>3 cumulative hours) in the past year
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
Audrey Nicoloff, 513-558-7487, strokerecovery@uc.udu
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Sasha Moores, 913-588-2697, reachlab@kumc.edu
Sandra Billinger, PT, PhD
- Recruiting
University of Delaware
Newark, Delaware, 19713
Jane Diehl, strokestudies@udel.edu
Darcy Reisman, PT, PhD
About this study
Official title: Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke: HIT-Stroke Trial 2
People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization.
- Conditions
- Stroke
- Being tested
- Moderate-Intensity Aerobic Training, High-Intensity Interval Training
- Keywords
- gait, aerobic, locomotion
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-Intensity Aerobic TrainingBehavioural
Overground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve.
High-Intensity Interval TrainingBehavioural
Overground and treadmill walking with 30 second bursts at maximum speed alternated with 30-60 second passive recovery periods. Intended to achieve a target average heart rate above 60% heart rate reserve.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-Intensity Aerobic Training | Active comparator | Not described Receives: Behavioral: Moderate-Intensity Aerobic Training |
| High-Intensity Interval Training | Experimental | Not described Receives: Behavioral: High-Intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Walk Test Distance
Total distance walked in 6 minutes in meters
Measured: Change from Baseline to 12 weeks
Secondary outcomes (6)
6-Minute Walk Test Distance
Total distance walked in 6 minutes in meters
Measured: Change from Baseline to 3 month follow up
Self-Selected Gait Speed
From 10-meter walk test at self-selected speed, in meters per second
Measured: Change from Baseline to 12 weeks
Fastest Gait Speed
From 10-meter walk test at fastest speed, in meters per second
Measured: Change from Baseline to 12 weeks
PROMIS-Fatigue Scale version 8a
An 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5. Items are combined to obtain a total T score, where higher scores indicate greater fatigue.
Measured: Change from Baseline to 3 month follow up
Aerobic Capacity
Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute
Measured: Change from Baseline to 12 weeks
EuroQol-5D-5L
A 6-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, anxiety/depression and overall health. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total 'misery score' will be calculated by averaging the scores for each item.
Measured: Change from Baseline to 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start9 Feb 2024
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Kansas Medical Center, University of Delaware
- Responsible party
- Principal investigator, Pierce Boyne, University of Cincinnati
- Investigators
- Pierce Boyne, PT, DPT, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268041
- Sponsor's protocol ID
- 427659
- Other IDs
- R01HD093694
- Acronym
- HST2
- Status last verified
- Apr 2026
- First submitted
- 12 Feb 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final, de-identified dataset and data documentation will be deposited into the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) archive
Publications
Pressler D, Schwab-Farrell SM, Awosika OO, Reisman DS, Billinger SA, Riley MA, Boyne P. Predicting Musculoskeletal Adverse Events During Moderate- to High-Intensity Walking Training in Chronic Stroke. medRxiv [Preprint]. 2026 Apr 18:2026.04.16.26351040. doi: 10.64898/2026.04.16.26351040.
PubMed 42064927Garrity C, Reisman DS, Billinger SA, Pressler D, Wagner E, Awosika O, Bartsch BL, Briton-Carpenter A, Carl D, Engler A, Foster J, Kim J, McCartney K, Moores A, Sucharew H, Thompson E, Walters K, Wasik E, Wright H, Yeazell M, Boyne P. Protocol for the HIT-Stroke Trial 2 randomized controlled trial: Moderate-intensity exercise versus high-intensity interval training to determine the optimal training intensity for walking rehabilitation in chronic stroke. medRxiv [Preprint]. 2025 Jul 31:2025.07.30.25332470. doi: 10.1101/2025.07.30.25332470.
PubMed 40766122
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke: HIT-Stroke Trial 2
- ClinicalTrials.gov ID
- NCT06268041
- Acronym / sponsor ID
- HST2 / 427659
- Conditions
- Stroke
- Keywords
- gait, aerobic, locomotion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Kansas Medical Center, University of Delaware
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-Intensity Aerobic Training | Active comparator | Behavioral: Moderate-Intensity Aerobic Training |
| High-Intensity Interval Training | Experimental | Behavioral: High-Intensity Interval Training |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 30-85 years at time of consenting
- Hemiparesis from ischemic and/or hemorrhagic strokes
- Most recent stroke for which participant sought treatment, at least 6 months prior to study consent
- Walking speed <1.0 m/s on the 10-meter walk test
- Able to walk 10m over ground with assistive devices as needed and no continuous physical assistance from another person (guarding and intermittent assistance for loss of balance allowed)
Key exclusion criteria (16 listed)
- Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG abnormality that makes exercise ECG uninterpretable for ischemia and no other clinical testing from the past year available to rule out these conditions)
- Evidence of significant arrhythmia or myocardial ischemia on treadmill ECG graded exercise test in the absence of recent (past year) more definitive clinical testing (e.g. stress nuclear imaging) with negative result
- Hospitalization for cardiac or pulmonary disease within past 3 months
- Implanted pacemaker or defibrillator with an upper heart rate limit that would interfere with exercise testing or prescription, or with unknown limit
- Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-Intensity Aerobic TrainingOverground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve. | Behavioural | Moderate-Intensity Aerobic Training |
| High-Intensity Interval TrainingOverground and treadmill walking with 30 second bursts at maximum speed alternated with 30-60 second passive recovery periods. Intended to achieve a target average heart rate above 60% heart rate reserve. | Behavioural | High-Intensity Interval Training |
Primary outcome
6-Minute Walk Test Distance
Time frame: Change from Baseline to 12 weeks
Total distance walked in 6 minutes in meters
6 secondary outcomes
6-Minute Walk Test Distance
Time frame: Change from Baseline to 3 month follow up
Self-Selected Gait Speed
Time frame: Change from Baseline to 12 weeks
Fastest Gait Speed
Time frame: Change from Baseline to 12 weeks
PROMIS-Fatigue Scale version 8a
Time frame: Change from Baseline to 3 month follow up
Aerobic Capacity
Time frame: Change from Baseline to 12 weeks
EuroQol-5D-5L
Time frame: Change from Baseline to 3 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 42064927Pressler D, Schwab-Farrell SM, Awosika OO, Reisman DS, Billinger SA, Riley MA, Boyne P. Predicting Musculoskeletal Adverse Events During Moderate- to High-Intensity Walking Training in Chronic Stroke. medRxiv [Preprint]. 2026 Apr 18:2026.04.16.26351040. doi: 10.64898/2026.04.16.26351040.
- Derived from this study: PubMed 40766122Garrity C, Reisman DS, Billinger SA, Pressler D, Wagner E, Awosika O, Bartsch BL, Briton-Carpenter A, Carl D, Engler A, Foster J, Kim J, McCartney K, Moores A, Sucharew H, Thompson E, Walters K, Wasik E, Wright H, Yeazell M, Boyne P. Protocol for the HIT-Stroke Trial 2 randomized controlled trial: Moderate-intensity exercise versus high-intensity interval training to determine the optimal training intensity for walking rehabilitation in chronic stroke. medRxiv [Preprint]. 2025 Jul 31:2025.07.30.25332470. doi: 10.1101/2025.07.30.25332470.
- Individual participant dataSharing planned: Yes. The final, de-identified dataset and data documentation will be deposited into the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) archive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierce Boyne, PT, DPT, PhD principal investigator
University of Cincinnati
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-Intensity Aerobic Training and High-Intensity Interval Training in people with Stroke, run by University of Cincinnati at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Audrey Nicoloff (513-558-7487, strokerecovery@uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute Walk Test Distance (time frame: Change from Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06268041, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.